Version 5

Olaparib

Medicine

Extended indication In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Olaparib
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Ovarian cancer
Extended indication In combination with durvalumab, paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm).
Proprietary name Lynparza
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action PARP inhibitor
Route of administration Unknown
Therapeutical formulation Coated tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2026
Expected Registration January 2027
Orphan drug No
Registration phase Clinical trials
Medicine sluice Broadly excluded

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Additional remarks NCT03737643

Expected patient volume per year

Patient volume < 100

Market share is generally not included unless otherwise stated.
References NKR2021 (1) Heitz F, Ataseven B, Staniczok C, Denkert C, Rhiem K, Hahnen E, Heikaus S, Moubarak M, Welz J, Dagres T, Vrentas V, Bommert M, Schneider S, Concin N, Harter P. Implementing HRD Testing in Routine Clinical Practice on Patients with Primary High-Grade Advanced Ovarian Cancer. Cancers (Basel). 2023 Jan 29;15(3):818. doi: 10.3390/cancers15030818. PMID: 36765776; PMCID: PMC9913091 (2)
Additional remarks In 2021 waren er 1.130 diagnoses epitheliaal ovariumcarcinoom, 142 diagnoses extraovarieel ovariumcarcinoom en 69 diagnoses tubacarcinoom. In totaal zijn dit 1.341 patiënten. Hiervan heeft 47% stadium 3 (630) en 26% stadium 4 (348), wat samen 978 patiënten betreft. Ongeveer 20% van deze patiënten heeft geen tumor BRCA1/2 mutatie (non-tBRCAm) (2). Op basis van de studie, betreft het alleen HRD+ patiënten. De inschatting van het patiënt volume is minder dan 100.

Expected cost per patient per year

References G-Standaard
Additional remarks €2.490 per verpakking van 56 tabletten.

Potential total cost per year

Off label use

Indication extension

Other information